Aspirin
FDA Label NDC 67510-0008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Aspirin (NDC 67510-0008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each tablet), purposes, uses, warnings, alcohol warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Tablet)

Aspirin 325mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • minor pain of arthritis
  • pain and fever of colds

Warnings

Reye's syndrome:Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert:Aspirin may cause a severe allergic reaction which may include:
  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

Alcohol Warning:

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain reliever/fever reducers. Aspirin may cause stomach bleeding.

Do Not Use

if you are allergic to aspirin or any other pain reliever/fever reducer

Ask A Doctor Before Use If You Have

  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • ulcers
  • asthma

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • anticoagulation (blood thinning)
  • gout
  • diabetes
  • arthritis

Stop Use And Ask A Doctor If

  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever lasts more than 3 days
  • ringing in the ears or loss of hearing occurs

If Pregnant Or Breast-Feeding,

ask a health professional before use.It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
  • children under 12 years: consult a doctor

Other Information

  • save carton for full directions and warnings
  • store at room temperature

Inactive Ingredients

dry starch, citric acid, carboxymethyl starch sodium, starch, starch paste

Package Label.Principal Display Panel

Aspirin

Image Of Bottle Label (Aspirin.carton)

Image Of Bottle Label (Aspirin.carton)

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